Quality Coordinator (Plasma Quality Release) - Evening Shift

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Job Description

Job Description

This role is responsible for reviewing documentation associated with plasma receipt and dispositioning, as well as release of acceptable plasma to production. Additional quality oversight is provided for Plasma Operations activities.

This position is also responsible for processing Post Donation (PDI) received from Plasma Suppliers and Testing Laboratories, to ensure the appropriate Category is assigned to the Notification/Observation and to ensure the plasma units in inventory are flagged for destruction.

Plasma Release

• Review documentation associated with plasma dispositioning and perform quality review and release for plasma to be used in Teardown in the Automated Plasma Dispositioning System (APDS).

• Review shipment documentation associated with plasma shipments received and perform quality review in the Automated Plasma Dispositioning System (APDS).

• Ensure destruction of unsuitable plasma units, as necessary and ensure proper documentation: perform required system transactions.

• Place shipments and plasma centers on hold and remove holds based on sufficient support documentation and approvals.

Lookback

• Process and/or verify Lookback/PDI Notifications/Observations received from plasma suppliers within the timeframe specified in department procedures and incompliance with regulatory requirements.

Quality System

• Initiate Deviations in Trackwise for internal discrepancies associated with Plasma Quality Release and Plasma Operations processes and for plasma supplier discrepancies; conduct investigations and identify corrective/preventative actions.

• Review and ensure discrepancies are documented, investigated, and resolved using the appropriate PQR Quality System according to set deadlines.

• Revise department owned procedures for compliance with Corporate, BioLife, and Regulatory requirements and implementation of continuous improvement initiatives as required.

• Utilize excellent grammar, mechanics and proofreading skills to generate clear, concise, and accurate documentation (e.g. NCE, Deviations, SCAR formal memorandums, electronic mail, etc.)

• Conduct process audits to ensure activities and documentation conform to standard operating procedures and regulatory requirements.

• File documentation according to procedural requirements and ensure retention policies are met.

Other

• Identify, lead and implement continuous improvement projects.

• Actively participate in internal or external audits as required (e.g. runner, communication flow, document reviewer, etc.) and support the closure of audit observations within the specified timeframe.

• Support special projects / protocols execution.

• Identify and inform PQR Management of plasma related discrepancies.

• Communicate with quality, manufacturing, technical support groups, and plasma supplier staff to ensure availability of plasma and to resolve plasma related discrepancies.

• Provide and present to management monthly statistical data for key metrics, such as plasma receipts, plasma on hold and other key information. Create and present PowerPoint slides for the purposes of presenting data, as required.

• Other duties as assigned